Healthy
Conditions
Brief summary
Study to assess the efficacy of ginsana in improving half-time hemoglobin re-oxygenation in healthy, recreational sportspeople and to assess the safety of the product
Interventions
DRUGGINSANA
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female volunteers between 18 and 40 years old * Females must test negative for pregnancy * Recreational athletes according to the american college of sports medicine (ACSM) definition * Familiar with the cycle ergometer exercise methodology * Written inform consent according to good clinical practice (GCP) and local regulations
Exclusion criteria
* Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that any drug that could have influence the trail methodology * Alcohol and drug abuse (as defined in Diagnostic and Statistic Manual IV( DSM-IV)) per subject verbal report * Smokers * Known hypertension * Known hypercholesterolemia (moderate/severe) * Female volunteers taking oral or injectable contraceptives * Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills \[intrauterine devices (IUDs)\] * Pregnancy and/or lactation * Liver and/or renal disease and/or vascular disease * Relevant allergy or known hypersensitivity to the investigational drug or its excipients * Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in half-time hemoglobin re-oxygenation by Near InfraRed Spectroscopy (NIRS) methodology | Baseline, day 84 post first drug dispense |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in half-time hemoglobin re-oxygenation by NIRS methodology | Baseline, day 21, 42 and 63 post first drug dispense |
| Maximum endurance time | up to day 84 post first drug dispense |
| Change from baseline in respiratory threshold | Baseline, up to day 84 post first drug dispense |
| Change from baseline in thiobarbituric acid (TBARS) | Baseline, up to day 84 post first drug dispense |
| Change from baseline in glutathion superdismutase / glutathion superdismutase oxidised (GSA/GSSG) | Baseline, up to day 84 post first drug dispense |
Outcome results
None listed